Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes

Diabetes Mellitus Clinical Trial

— FitKidney  

Official title:

Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015480
• Other study ID #: 2016-0382
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: November 25, 2018

Study information

• Verified date: February 2019
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study tests the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.

Description:

Patients with diabetes and stage 1-3a CKD receive instructions on downloading and using MyFitnessPal on their smartphone or computer to log meal data daily, weekly website educational materials, and weekly telephone visits with a dietician for 8 weeks. Patients receive a follow-up phone call from the dietitian and 5 and 11 months for further support and counseling, and are also invited to attend a local dietitian-led grocery tour. This pilot study examines the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.

Main outcomes include sodium intake assessed by 24 hour urine collection as well as other dietary measures related to kidney disease (sodium/potassium ratio, Healthy Eating Index score, 24-hour urine phosphorus, estimated net endogenous acid production) and health measures (24-hour ambulatory blood pressure, weight, albumin/creatinine ratio)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 25, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age > 21 years

• Diabetes diagnosis (Type I or Type II)

• Last urine albumin/creatinine ratio (ACR) within the past two years > 30 mg/g

• Last outpatient estimated glomerular filtration rate (eGFR) within the past year > 45 ml/min/1.73m2

• Last outpatient systolic blood pressure (SBP) within the past year < 160 mmHg

• Last outpatient diastolic blood pressure (DBP) within the past year <100 mmHg

• Preceding eGFR decline rate less than -2 ml/min/1.73m2/y

• At least 2 outpatient eGFR measurements in electronic health record, separated by at least 2 years

• Agreeable to change diet (decrease sodium and red/processed meat intake, increase fruit and vegetable intake)

• Access to smartphone or computer

Exclusion Criteria:

• Inability to understand English

• Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within 6 months.

• Current treatment for malignancy

• Planned bariatric surgery

• Pregnancy or planning to become pregnant within next 2 years

• Self-reported average consumption of > 14 alcoholic beverages per week

• Psychiatric hospitalization in past year

• Unstable angina

• Urine ACR > 2500 mg/g

• Last potassium > 5.0 mg/dL

• Hypoglycemia episode in past 1 month (glucose < 70 mg/dL)

• Principal investigator discretion (i.e. concerns about safety, compliance)

Related Conditions & MeSH terms

• Albuminuria
• Chronic Kidney Disease
• Diabetes Mellitus
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Remote counseling
For an 8 week period, patients will be asked to enter dietary information into the MyFitnessPal mobile application or website. Dietitians will access this information and provide personalized motivational interview phone calls on a weekly basis. After the initial 8 weeks, patients will receive a dietitian follow-up phone call around 5 and 11 months later.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour urine sodium	unadjusted and adjusted for creatinine excretion	baseline to 12 months
Secondary	Change in 24-hour Ambulatory Systolic Blood Pressure		baseline to 12 months
Secondary	Change in urine sodium/potassium ratio		baseline to 12 months
Secondary	Change in Healthy Eating Index (HEI) score	Assessed by three 24-hour dietary recalls obtained by phone at each time point	baseline to 12 months
Secondary	Change in 24-hour Urine Albumin Excretion	unadjusted and adjusted for creatinine excretion	baseline to 12 months
Secondary	Change in weight		baseline to 12 months
Secondary	Change in 24-hour urine phosphorus	unadjusted and adjusted for creatinine excretion	baseline to 12 months
Secondary	Change in Net Endogenous Acid Production (NEAP)	NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])	baseline to 12 months

External Links

•   Educational website that is provided to the patients.